United States - English - NLM (National Library of Medicine)

genentech, inc. - vemurafenib (unii: 207smy3fqt) (vemurafenib - unii:207smy3fqt) - vemurafenib 240 mg - zelboraf® is indicated for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fda-approved test. limitation of use: zelboraf is not indicated for treatment of patients with wild-type braf melanoma [see warnings and precautions (5.2)] . zelboraf® is indicated for the treatment of patients with erdheim-chester disease (ecd) with braf v600 mutation. none. risk summary based on its mechanism of action, zelboraf can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of zelboraf in pregnant women to determine the drug-associated risk; however, placental transfer of vemurafenib to a fetus has been reported. exposure to vemurafenib could not be achieved in animals at levels sufficient to fully address its potential toxicity in pregnant women. advise pregnant women of the potential harm to a fetus. the estimated background risks of major birth defects and miscarriage for the indicated population(s) are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data vemurafenib showed no evidence of developmental toxicity in rat fetuses at doses up to 250 mg/kg/day (approximately 1.3 times the clinical exposure at 960 mg twice daily based on auc) or rabbit fetuses at doses up to 450 mg/kg/day (approximately 0.6 times the clinical exposure at 960 mg twice daily based on auc). fetal drug levels were 3–5% of maternal levels, indicating that vemurafenib has the potential to be transmitted from the mother to the developing fetus. there is no information available regarding the presence of vemurafenib in human milk, effects on the breastfed infant, or effects on milk production. because of the potential for serious adverse reactions in a breastfed infant, including malignancy, severe dermatologic reactions, qt prolongation, hepatotoxicity, photosensitivity, and ophthalmologic toxicity, [see warnings and precautions (5)] , advise women not to breastfeed during treatment with zelboraf and for 2 weeks after the final dose. contraception based on its mechanism of action, zelboraf can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with zelboraf and for 2 weeks after the final dose. the safety and effectiveness of zelboraf in pediatric patients have not been established. vemurafenib was studied in 6 adolescent patients 15 to 17 years of age with unresectable or metastatic melanoma with braf v600 mutation. a maximum tolerated dose was not reached with doses up to vemurafenib 960 mg twice daily. no new safety signals were observed. vemurafenib steady-state exposure in these 6 adolescent patients was generally similar to that in adults. clinical studies of zelboraf did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. no formal clinical study has been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of vemurafenib. no dose adjustment is recommended for patients with mild and moderate hepatic impairment based on a population pharmacokinetic analysis [see clinical pharmacology (12.3)]. the appropriate dose of zelboraf has not been established in patients with severe hepatic impairment. no formal clinical study has been conducted to evaluate the effect of renal impairment on the pharmacokinetics of vemurafenib. no dose adjustment is recommended for patients with mild and moderate renal impairment based on a population pharmacokinetic analysis [see clinical pharmacology (12.3)]. the appropriate dose of zelboraf has not been established in patients with severe renal impairment.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - vemurafenib - film coated tablets - vemurafenib 240 mg - vemurafenib - vemurafenib - zelboraf is indicated for the treatment of brafv600 mutation-positive unresectable or metastatic melanoma.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - vemurafenib, quantity: 800 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; croscarmellose sodium; titanium dioxide; magnesium stearate; iron oxide red; hyprolose; purified talc; polyvinyl alcohol; macrogol 3350 - zelboraf is indicated for the treatment of unresectable stage iiic or stage iv metastatic melanoma positive for a braf v600 mutation.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - vemurafenib - melanoma - antineoplastic agents - vemurafenib is indicated in monotherapy for the treatment of adult patients with braf-v600-mutation-positive unresectable or metastatic melanoma.,

Singapore - English - HSA (Health Sciences Authority)

roche singapore pte. ltd. - vemurafenib in hypromellose acetate succinate 800mg eqv to vemurafenib - tablet, film coated - 240mg - vemurafenib in hypromellose acetate succinate 800mg eqv to vemurafenib 240mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - vemurafenib - tablet - 240mg

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - vemurafenib 240mg (as a co-precipitate with hypromellose acetate succinate (800 mg total));  ;   - film coated tablet - 240 mg - active: vemurafenib 240mg (as a co-precipitate with hypromellose acetate succinate (800 mg total))     excipient: colloidal silicon dioxide croscarmellose sodium hyprolose iron oxide red macrogol 3350 magnesium stearate polyvinyl alcohol purified talc titanium dioxide - indicated for the treatment of unresectable stage iiic or stage iv metastatic melanoma positive for the braf v600 mutation.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

roche (malaysia) sdn. bhd. - vemurafenib -

Canada - English - Health Canada

hoffmann-la roche limited - vemurafenib - tablet - 240mg - vemurafenib 240mg - antineoplastic agents

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - vemurafenib -